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Completed

NCT Number: NCT06004596

Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)

The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally.

Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairn Diagnostics, Brentwood, Tennessee, United States

Loading trial locations.

About this study

Children will complete questionnaires to ensure that they are qualified to enter the study and are likely to have normal gastric emptying rates. Informed consent/assent will be obtained.

Breath samples will be collected by children blowing into test tubes before and after eating a 13C-Spirulina GEBT meal. Breath samples will be collected and the test will be administered via telehealth or at one of the children's hospital clinics.

Researchers will analyze results from different age groups to see if there are differences in normal gastric emptying in younger/older children and boys/girls.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children ages 7 to 18 years who provide written assent and whose parents provide written consent for participation
  • Healthy and without any significant prior medical history or developmental delays
  • Able to eat the test meal and provide breath samples.-

Exclusion criteria

Any known physician-diagnosed medical (gastrointestinal, pancreatic, or liver disease that may cause malabsorption, neurological) or psychiatric disease

  • Chronic pulmonary disease including moderate/severe reactive airway disease requiring treatment with a daily inhaler
  • Type 1 or 2 Diabetes
  • Chronic gastrointestinal symptoms or functional gastrointestinal disorders
  • Mental retardation or pervasive developmental disorder
  • Currently receiving prescription drug therapy that may affect gastric motor function or sensation
  • Any over-the-counter or herbal supplements that may affect gastric motor function or sensation
  • Allergy to Spirulina, egg, milk, wheat or gluten (unless consuming gluten free crackers with the test meal) or known intolerance to any ingredient in the test meal

Treatment and study plan

13C-Spirulina Gastric Emptying Breath Test (GEBT)

Diagnostic Test

Diagnostic test

13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat

Diagnostic Test

Diagnostic test - repeat for biological variability deterination

Primary outcomes

  1. kPCD (kPCD = 1000 x percent dose of 13C excreted) at 15 minutes (min-1)

    Time frame: 15 minutes

    13CO2 excretion rate calculated at 15 minutes after meal completion

  2. kPCD at 30 minutes (min-1)

    Time frame: 30 minutes

    13CO2 excretion rate calculated at 30 minutes after meal completion

  3. kPCD at 45 minutes (min-1)

    Time frame: 45 minutes

    13CO2 excretion rate calculated at 45 minutes after meal completion

  4. kPCD at 60 minutes (min-1)

    Time frame: 60 minutes

    13CO2 excretion rate calculated at 60 minutes after meal completion

  5. kPCD at 90 minutes (min-1)

    Time frame: 90 minutes

    13CO2 excretion rate calculated at 90 minutes after meal completion

  6. kPCD at 120 minutes (min-1)

    Time frame: 120 minutes

    13CO2 excretion rate calculated at 120 minutes after meal completion

  7. kPCD at 150 minutes (min-1)

    Time frame: 150 minutes

    13CO2 excretion rate calculated at 150 minutes after meal completion

  8. kPCD at 180 minutes (min-1)

    Time frame: 180 minutes

    13CO2 excretion rate calculated at 180 minutes after meal completion

  9. kPCD at 210 minutes

    Time frame: 210 minutes

    13CO2 excretion rate calculated at 210 minutes after meal completion

  10. kPCD at 240 minutes (min-1)

    Time frame: 240 minutes

    13CO2 excretion rate calculated at 240 minutes after meal completion

  11. Test meal/test completion

    Time frame: up to 20 minutes

    Participant was able to successfully consume the meal/complete the test - Measured by determining whether box on test request form checked or not checked and whether or not all breath samples were collected/able to be analyzed

  12. Tmax (mins)

    Time frame: 90 to 240 minutes

    Time of maximum excretion rate - time at which the largest kPCD is observed

Sponsors and collaborators

Lead sponsor

Cairn Diagnostics

Industry

Collaborators

  • Baylor College of Medicine
  • Medical College of Wisconsin

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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